Sunitinib Msn

Package Leaflet: Information for the User

Sunitinib MSN, 12.5 mg, hard capsules

Sunitinib MSN, 25 mg, hard capsules Sunitinib MSN, 37.5 mg, hard capsules

Sunitinib MSN, 50 mg, hard capsules

Sunitinib

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of Contents of the Leaflet:

• 1. What is Sunitinib MSN and what is it used for
• 2. Important information before taking Sunitinib MSN
• 3. How to take Sunitinib MSN
• 4. Possible side effects
• 5. How to store Sunitinib MSN
• 6. Contents of the pack and other information

1. What is Sunitinib MSN and what is it used for

Sunitinib MSN contains the active substance sunitinib, which is a protein kinase inhibitor.
The medicine is used to treat cancer by preventing the activity of a special group of
proteins known to be involved in the growth and spread of cancer cells.
Sunitinib MSN is used to treat the following types of cancer in adults:

• Gastrointestinal stromal tumors (GIST), a type of stomach and intestine cancer, when imatinib (another anticancer medicine) has stopped working or the patient cannot take imatinib.
• Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
• Pancreatic neuroendocrine tumors (pNET) (tumors that arise from hormone-producing cells in the pancreas) that are progressing or cannot be surgically removed.

If you have any questions about how Sunitinib MSN works or why it has been prescribed for you, you should ask your doctor.

2. Important information before taking Sunitinib MSN

When not to take Sunitinib MSN

• if you are allergic to sunitinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Sunitinib MSN, you should discuss it with your doctor:

• - If you have high blood pressure. Sunitinib MSN may increase blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib MSN, and you may need to be treated with blood pressure-lowering medicines.
• - If you have or have had bleeding or blood disorders. Treatment with Sunitinib MSN may increase the risk of bleeding or change the number of certain blood cells, which can cause anemia or affect the blood's ability to clot. If you are taking warfarin or acenocoumarol, blood-thinning medicines used to prevent blood clots, there may be a higher risk of bleeding. You should tell your doctor about any bleeding during treatment with Sunitinib MSN.
• - If you have heart disease. Sunitinib MSN may cause heart disease. You should tell your doctor if you experience extreme fatigue, shortness of breath, or swelling of the feet and ankles.
• - If you have heart rhythm disorders. Sunitinib MSN may cause heart rhythm disorders. During treatment with Sunitinib MSN, your doctor may perform an electrocardiogram to assess these disorders. You should tell your doctor if you experience dizziness, fainting, or irregular heartbeat during treatment with Sunitinib MSN.
• - If you have had blood clots in the veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.You should contact your doctor immediately if you experience symptoms such as chest pain or tightness, arm, back, neck, or jaw pain, shortness of breath, numbness or weakness on one side of the body, difficulty speaking, headache, or dizziness.
• - If you have or have had an aneurysm (enlargement and weakening of the wall of a blood vessel) or a tear in the wall of a blood vessel.
• - If you have or have had damage to the smallest blood vessels, known as thrombotic microangiopathy.You should tell your doctor if you experience fever, fatigue, weakness, bruising, bleeding, swelling, confusion, vision loss, and seizures.
• - If you have thyroid gland disease. Sunitinib MSN may cause thyroid gland disease. You should tell your doctor if you easily get tired, feel colder than other people, or experience a deepened voice during treatment with Sunitinib MSN. Your doctor should check your thyroid function before starting treatment with Sunitinib MSN and regularly during treatment. If your thyroid gland does not produce enough thyroid hormone, you may need to be treated with replacement thyroid hormone.
• - If you have or have had pancreatic disorders or gallbladder disease.You should tell your doctor if you experience any of the following symptoms: stomach pain (upper abdomen), nausea, vomiting, and fever. These may be symptoms of pancreatitis or gallbladder inflammation.
• - If you have or have had liver disease.You should tell your doctor if you experience any of the following liver-related symptoms: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the right upper abdomen. Your doctor should perform blood tests to check your liver function before starting treatment with Sunitinib MSN, during treatment, and if there are clinical signs.

if you experience any of the following liver-related symptoms: itching, yellowing of the eyes or skin, dark urine, or pain or discomfort in the right upper abdomen. Your doctor should perform blood tests to check your liver function before starting treatment with Sunitinib MSN, during treatment, and if there are clinical signs.

• - If you have or have had kidney disease. Your doctor will monitor your kidney function.
• - If you are going to have surgery or have recently had surgery. Sunitinib MSN may affect wound healing. Sunitinib MSN is usually discontinued in patients before surgery. Your doctor will decide when to restart Sunitinib MSN.
• It is recommended that you have a dental check-up before starting treatment with Sunitinib

MSN:

• if you experience pain in the mouth, tooth pain, and/or jaw pain, swelling or ulceration of the mouth, numbness or a feeling of heaviness in the jaw, or tooth mobility, you should immediately inform your oncologist and dentist.
• if you need invasive dental treatment or oral surgery, you should inform your dentist that you are taking Sunitinib MSN, especially if you are also taking or have taken intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone problems, which may be taken for another condition.
• - If you have or have had skin and subcutaneous tissue disorders.During treatment with this medicine, you may experience "pyoderma gangrenosum" (painful skin ulcers) or "necrotizing fasciitis" (a rapidly spreading infection of the skin and/or soft tissues that can be life-threatening). You should contact your doctor immediately if you experience symptoms of infection around a skin injury, including fever, pain, redness, swelling, or discharge of pus or blood. These disorders usually resolve after discontinuation of sunitinib treatment. During treatment with sunitinib, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been observed, which initially appear as reddened patches with a target-like shape or round patches, often with centrally located blisters. The rash may progress to widespread blisters or peeling of the skin and can be life-threatening. If you experience a rash or the above-mentioned skin symptoms, you should contact your doctor immediately.
• - If you have or have had seizures. You should inform your doctor as soon as possible if you experience high blood pressure, headache, or vision loss.
• - If you have diabetes. In patients with diabetes, blood sugar levels should be regularly checked to assess whether it is necessary to adjust the dose of the anti-diabetic medicine to minimize the risk of low blood sugar. You should inform your doctor as soon as possible if you experience symptoms related to low blood sugar (fatigue, palpitations, excessive sweating, hunger, and loss of consciousness).

Children and adolescents

Sunitinib MSN is not recommended for use in children and adolescents under 18 years of age.

Sunitinib MSN and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take.
Some medicines may affect the levels of Sunitinib MSN in your body. You should inform your doctor if you are taking medicines containing the following active substances:

• ketokonazole, itraconazole - used to treat fungal infections
• erythromycin, clarithromycin, rifampicin - used to treat infections
• ritonavir - used to treat HIV infection
• dexamethasone - a corticosteroid used to treat various disorders (such as allergies/respiratory disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital - used to treat epilepsy and other neurological disorders
• herbal preparations containing St. John's Wort (Hypericum perforatum) - used to treat depression and anxiety disorders.

Sunitinib MSN with food and drink

While taking Sunitinib MSN, you should not drink grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Women who may become pregnant should use effective contraception during treatment with Sunitinib MSN.
Women who are breastfeeding should tell their doctor. You should not breastfeed while taking Sunitinib MSN.

Driving and using machines

If you experience dizziness or extreme fatigue, you should be careful while driving or operating machinery.

Sunitinib MSN contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Sunitinib MSN

This medicine should always be taken exactly as your doctor has told you. If you are unsure, you should ask your doctor.
Your doctor will prescribe the dose of Sunitinib MSN that is right for you, depending on the type of cancer. For patients being treated for:

• -GIST or MRCC: the usual dose is 50 mg taken once a day for 28 days (4 weeks), followed by a 14-day (2-week) break (without medicine), in 6-week treatment cycles.
• pNET: the usual dose is 37.5 mg taken once a day continuously.

Your doctor will determine the right dose for you and whether you should stop treatment with Sunitinib MSN.
Sunitinib MSN can be taken with or without food.

If you take more Sunitinib MSN than you should

If you accidentally take too many capsules, you should contact your doctor immediately. Medical attention may be necessary.

If you forget to take Sunitinib MSN

You should not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Sunitinib MSN can cause side effects, although not everybody gets them.
You should contact your doctor immediately if you experience any of the following serious side effects (see also “Important information before taking Sunitinib MSN”).
Heart disease. You should tell your doctor if you feel extremely tired, have shortness of breath, or swelling of the feet and ankles. These may be symptoms of heart problems, which can include heart failure and problems with the heart muscle (cardiomyopathy).
Lung disease or breathing difficulties.You should tell your doctor if you experience coughing, chest pain, sudden shortness of breath, or coughing up blood. These may be symptoms of a condition called pulmonary embolism, which occurs when blood clots move to the lungs.
Kidney problems. You should tell your doctor if you experience disturbed or absent urination, which may be a sign of kidney failure.
Bleeding. You should tell your doctor if you experience any of the following symptoms or serious bleeding problems: painful, swollen abdomen (stomach); vomiting blood; black, tarry stools; blood in urine; headache or changes in consciousness; coughing up blood or bloody sputum from the lungs or airways.
Tumor lysis syndrome leading to intestinal perforation. You should tell your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in stool, or changes in bowel habits.
Other side effects that may occur during treatment with Sunitinib MSN include:

• Very common: may affect more than 1 in 10 people
• Decreased number of platelets, red blood cells, and/or white blood cells (e.g., neutrophils).
• Shortness of breath.
• High blood pressure.
• Extreme fatigue, loss of strength.
• Swelling caused by fluid accumulation under the skin and around the eyes, deep allergic rash.
• Pain/inflammation in the mouth, mouth ulcers/inflammation of the mucous membrane of the mouth, dry mouth, changes in taste, stomach upset, nausea, vomiting, diarrhea, constipation, abdominal pain/swelling, loss of appetite.
• Decreased thyroid activity (hypothyroidism).
• Dizziness.
• Headache.
• Nosebleeds.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellowing/discoloration of the skin, excessive skin pigmentation, hair color changes, palmar-plantar erythrodysesthesia, rash, dry skin.
• Coughing.
• Fever.
• Sleep disturbances.

Common: may affect up to 1 in 10 people

• Blood clots in blood vessels.
• Insufficient blood flow to the heart muscle due to blockage or narrowing of the coronary arteries.
• Chest pain.
• Decreased amount of blood pumped by the heart.
• Fluid accumulation around the heart (pericardial effusion).
• Infections.
• A severe complication of infection (sepsis), which can lead to tissue damage, organ failure, and death.
• Decreased blood sugar levels (see section 2).
• Protein loss in the urine, sometimes causing swelling.
• Pseudo-flu syndrome.
• Abnormal blood test results, including pancreatic and liver enzymes.
• High levels of uric acid in the blood.
• Hemorrhoids, anal pain, gum bleeding, difficulty swallowing or loss of swallowing ability.
• Burning sensation or pain in the tongue, inflammation of the mucous membrane of the digestive tract, excessive gas in the stomach or intestines.
• Weight loss.
• Musculoskeletal pain (muscle and bone pain), muscle weakness, muscle fatigue, muscle cramps.
• Dryness of the nasal mucous membrane, feeling of nasal congestion.
• Excessive tearing.
• Disorders of skin sensation, itching, skin peeling and inflammation, blisters, acne, nail discoloration, hair loss.
• Disorders of sensation in the limbs.
• Disorders related to increased or decreased sensitivity, especially to touch.
• Heartburn.
• Dehydration.
• Hot flashes.
• Abnormal urine color.
• Depression.
• Chills.

Uncommon: may affect up to 1 in 100 people

• Life-threatening infection of soft tissues, including the area around the anus and genital organs (see section 2).
• Stroke.
• Heart attack caused by interruption or reduction of blood flow to the heart.
• Changes in the electrical or irregular heartbeat.
• Fluid accumulation around the heart (pericardial effusion).
• Liver failure.
• Abdominal pain (stomach) caused by pancreatitis.
• Tumor lysis syndrome leading to intestinal perforation (perforation).
• Inflammation (swelling and redness) of the gallbladder with or without gallstones.
• Formation of abnormal connections between one body cavity and another or with the skin.
• Pain in the mouth, tooth pain, and/or jaw pain, swelling or ulceration of the mouth, numbness or a feeling of heaviness in the jaw, or tooth mobility. These may be symptoms of jawbone damage (osteonecrosis), see section 2.
• Excessive production of thyroid hormones leading to increased energy expenditure by the body at rest.
• Abnormal wound healing after surgery.
• Increased activity of the muscle enzyme (creatine phosphokinase) in the blood.
• Excessive allergic reaction, including hay fever, skin rash, itching, hives, swelling of body parts, and breathing difficulties.
• Inflammation of the large intestine (colitis, ischemic colitis).

Rare: may affect up to 1 in 1,000 people

• Severe skin and mucous membrane reaction (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumor lysis syndrome, which includes a group of metabolic complications that can occur during cancer treatment. These complications are caused by the breakdown products of dying cancer cells and can include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and abnormal laboratory test results (high levels of potassium, uric acid, and phosphorus, and low levels of calcium in the blood), which can lead to changes in kidney function and acute kidney failure.
• Abnormal muscle breakdown, which can lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain, which can cause a range of symptoms, including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulcers (pyoderma gangrenosum).
• Hepatitis.
• Thyroid inflammation.
• Damaged smallest blood vessels, known as thrombotic microangiopathy.

Frequency not known (frequency cannot be estimated from the available data)

• Enlargement and weakening of the wall of a blood vessel or rupture of the wall of a blood vessel (aneurysm and arterial dissection).
• Lack of energy, confusion, drowsiness, loss of consciousness, or coma - these symptoms may be signs of the toxic effect of high ammonia levels in the blood on the brain (hyperammonemic encephalopathy).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Sunitinib MSN

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister after: EXP. The expiry date refers to the last day of the month.
Blister
Store in a temperature below 30°C.
Bottle
Store in a temperature below 25°C.
Do not use the medicine if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sunitinib MSN contains

The active substance of Sunitinib MSN is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg, 25 mg, 37.5 mg, or 50 mg of sunitinib. The other ingredients are:

• Contents of the capsule:mannitol (E 421), croscarmellose sodium, corn starch, magnesium stearate.
• Capsule shell:gelatin, purified water, titanium dioxide (E 171), iron oxide red (E 172) (for 12.5 mg, 25 mg, and 50 mg strengths), iron oxide black (E 172) (for 25 mg and 50 mg strengths), iron oxide yellow (E 172) (for 25 mg, 37.5 mg, and 50 mg strengths).
• Printing ink:shellac (E 904), propylene glycol (E 1520), potassium hydroxide (E 525), titanium dioxide (E 171) (for 12.5 mg, 25 mg, and 50 mg strengths), iron oxide black (E 172) (for 37.5 mg strength).

What Sunitinib MSN looks like and contents of the pack

Sunitinib MSN, 12.5 mg, is available as hard, gelatin capsules, size 4 (approximately 15 mm in length), with an orange, opaque body and an orange, opaque cap, with white printing "6" on the body and "MS" on the cap, filled with a yellow granular powder.
Sunitinib MSN, 25 mg, is available as hard, gelatin capsules, size 3 (approximately 16 mm in length), with an orange, opaque body and a caramel, opaque cap, with white printing "7" on the body and "MS" on the cap, filled with a yellow granular powder.
Sunitinib MSN, 37.5 mg, is available as hard, gelatin capsules, size 3 (approximately 16 mm in length), with a yellow, opaque body and a yellow, opaque cap, with black printing "8" on the body and "MS" on the cap, filled with a yellow granular powder.
Sunitinib MSN, 50 mg, is available as hard, gelatin capsules, size 2 (approximately 18 mm in length), with a caramel, opaque body and a caramel, opaque cap, with white printing "8" on the body and "MS" on the cap, filled with a yellow granular powder.
The medicine is available in bottles of 28 or 30 capsules and in single-dose blisters containing 14 x 1, 28 x 1, or 30 x 1 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147

Manufacturer/Importer:

Pharmadox Healthcare Limited
KW20A, Kordin Industrial Park
Paola, PLA3000
Malta
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal:
Sunitinib MSN
Czech Republic:
Sunitinib MSN
Slovakia:
Sunitinib MSN 12.5 mg
Sunitinib MSN 25 mg
Sunitinib MSN 37.5 mg
Sunitinib MSN 50 mg
Poland:
Sunitinib MSN
Romania:
Sunitinib MSN 12.5 mg capsule
Sunitinib MSN 25 mg capsule
Sunitinib MSN 37.5 mg capsule
Sunitinib MSN 50 mg capsule
Hungary:
Sunitinib MSN 12.5 mg hard capsule
Sunitinib MSN 25 mg hard capsule
Sunitinib MSN 37.5 mg hard capsule
Sunitinib MSN 50 mg hard capsule
Bulgaria:
Sunitinib MSN 12.5 mg твърди капсули
Sunitinib MSN 25 mg твърди капсули
Sunitinib MSN 37.5 mg твърди капсули
Sunitinib MSN 50 mg твърди капсули
Cyprus:
Sunitinib MSN 12.5 mg καψάκια σκληρά
Sunitinib MSN 25 mg καψάκια σκληρά
Sunitinib MSN 50 mg καψάκια σκληρά
Croatia:
Sunitinib MSN 12.5 mg tvrde kapsule
Sunitinib MSN 25 mg tvrde kapsule
Sunitinib MSN 50 mg tvrde kapsule
Slovenia:
Sunitinib MSN 12.5 mg trde kapsule
Sunitinib MSN 25 mg trde kapsule
Sunitinib MSN 50 mg trde kapsule

Date of last revision of the leaflet: 01/2025